Regulatory Requirements of Quality Assurance Program in Nuclear Medicine – Review of the Procedures

1Doctoral Study Center for Life and Health Sciences, Faculty of Medicine and Pharmacy of Rabat, Impasse Souissi, Rabat 10100, Morocco. 2Nuclear Medicine Department, IBN SINA Hospital Ibn Sina Rabat University Hospital Center, Avenue Abderrahim Bouabid, Rabat. 3PET Scan Rabat, Al Azhar Oncology Center, Angle, Rue Ouezzane, Rue Idriss Al Azhar, Rabat. *Corresponding Author E-mail: reda_hallab@um5.ac.ma

Quality assurance is defined as all planned and methodical actions necessary to assure that a structure, system or component will work successfully in service according to the International Organization for Standardization (ISO); indeed, satisfactory performance in diagnostic nuclear medicine implies optimal quality of the entire process 1 . Indeed, the regulatory requirements at the national level, in particular Law 142-12 2 , encourage the obligation to define and implement a quality assurance program in an installation using sources of ionizing radiation. During this study, we have reviewed various regulatory requirements from different countries (France, Belgium, and Switzerland) and the published scientific work of the International Atomic Energy Agency (IAEA), which states that an optimal quality of the whole process and the procedures of the quality assurance program ensure satisfactory performance in nuclear medicine, particularly in diagnostic and therapeutic areas 1 . Review of the procedures made it possible to have a global perspective of radiation protection requirements in a nuclear medicine facility and to try to find avenues for improvement for the procedures of the quality assurance. During this research, recommendations were made to encompass the full range of quality assurance in nuclear medicine.

Procedures of quality assurance program Justification
Various works reviewed in this paragraph encourage that the principle of justification be present in the quality assurance program, specifically; the procedures implementing the principle of justification are present in the said program: the stages from receipt of the request act until the decision to execute it 3 . According to the principle of justification, a practitioner in a medical establishment (nuclear medicine) can only practice if it is justified 4 . Various points are identified while prescribing an examination in a medical facility (nuclear medicine), such as the patient's identity, the assessment of the advisability of executing the radiological act, the presence of any contraindications, and good patient preparation 5 . Medical applications of ionizing radiation must be justified in terms of radiation protection and safety by comparing the advantages of exposure against the risk of radiation harm and examining alternative procedures that do not entail medical exposure 6 .

Optimisation
The application of the requirements of the optimization principal procedures is present in the quality assurance program, specially: • Identification the roles and responsibilities of each function of the stakeholders involved in the implementation of optimization procedures 3; • The written procedures by type of act as well as the methods of their preparation 3 ; • The processes for treating high-risk patient groups, such as women of childbearing age, pregnant women, and children, as well as persons with problems that necessitate periodic examinations 3 .
The essential precautions about the importance of notifying the existence or possibility of pregnancy in a woman undergoing a radiological examination, or in the event of the administration of radioactive products to the nursing woman 4 .

Quality control
The protocols for checking medical devices after receipt and before use, as well as the procedures for performing medical device maintenance and quality control, included when a change in software version has an impact on the dose or image quality 3 . The quality assurance program, in accordance with international standards and recommendations, must include all quality control modalities, including radiopharmaceuticals 7 . Quality control procedures must be performed on a regular and planned basis, and they must include acknowledged useful technologies. It is important that the facilities using ionizing radiation sources adhere to applicable requirements instituted from regulatory bodies, the purpose it's to be in compliance at all times 8 . Quality control is a critical for routine nuclear medicine practice 9 .

Training of professionals
According to some of the work reviewed, professional training is critical in the quality assurance program, specifically: the training and qualification procedures for professionals are specified in the quality assurance program for any newcomer when changing their position, workstation, or medical equipment 3 . Implementation of appropriate training for all professionals with responsibility for quality assurance. It also includes the implementation of continuing education sessions to keep employees up to date for the benefit of professionals participating in the medical facility's quality assurance 8 .

Record system
The quality assurance program provides for the development of a recording system, which will be beneficial in the event of a material, human, or organizational incident that is likely to result in the accidental or unintentional exposure of individuals during a medical imaging procedure 3 . The recording system includes the dates of detection and recording of the incident, a description of the event, the circumstances surrounding its occurrence and its consequences, and mechanisms for notifying the exposed person or his representative 3 .
The system also provides records of equipment performance, radiopharmaceutical and nuclear

Audit system
The quality assurance program should include the audit system 1 . Il is divided into three phases: self-assessment, internal clinical audit, and external clinical audit, the clinical audit must be documented at each step 4 . Quality Management Audits in Nuclear Medicine (QUANUM) is a program developed by the International Atomic Energy Agency to assist its member states in auditing the status of their nuclear medicine practices and their adherence to international standards, the program covers all aspects of nuclear medicine, in particularly quality assurance and control of instrumentation 10 .

Review of the procedures to the assurance quality program
Reviewing the procedures of the quality assurance program for the different regulatory requirements and scientific work. This revealed that most of the procedures are similar for the different works; it is suggested to add the review and assessment phase in the quality assurance program as a step that assesses all the program procedures 8 . To do this, an organization chart is proposed listing all the procedures of the quality assurance program:

CONCLUSION
The adoption of a quality assurance system allows the establishment of a radiation protection culture, thus ensuring radiation protection within a nuclear medicine or radiography facility. Furthermore, this is in accordance with regulatory requirements and international recommendations. During our review of the various regulatory requirements of the procedures of the quality assurance program and the scientific work as well as the evaluation of all the procedures of the said program. It was concluded that most of the reviewed works take into account most of the radiation safety and radiation protection requirements of the procedures of the quality assurance program. The result was the addition of the review and evaluation phase to the said program (flowchart established) according to the reviewed works. Its importance lies mainly in the improvement of medical procedures using ionizing radiation sources in nuclear medicine. This improvement must be continuous, which will minimize the risk of adverse events occurring in a nuclear medicine facility. For future research, we recommend that the regulatory requirements for quality assurance of radioactive waste generated by nuclear medicine facilities (imaging and therapy) be reviewed.